Quality Assurance

Avalign is committed to exceeding customer expectations through adherence to continual improvement principals and the deployment of a robust Quality System.

Key strategies critical to driving continuous improvement:

Customer Focus – Ensuring that we maintain Quality Systems which meet all customer requirements. We understand it is our responsibility to consistently deliver quality product to our customers, while operating a robust Quality System. The Avalign Quality System is designed to comply with all appropriate US/International regulatory requirements coupled with the specific quality system specifications of our OEM customers.

Quality – Employees understand that Quality is not negotiable. Quality objectives must be met without exception. Quality is not limited to our operators who touch the product; it is part of everyone’s job. We are continuously educating our employees that each of us plays an important role in ensuring our products always meet our customer requirements.

Measurement – We are committed to maintaining a Quality System which is consistent and standardized across all sites. A key method of maintaining adequate oversight of the Avalign Quality System is the routine use of performance metrics.

How do we deliver quality services and products?

Metrics and Communication – Avalign has established key quality indicators which are shared and communicated throughout all levels of the organization. Meetings are routinely held throughout the company to review and discuss performance trends and monitor action plans where appropriate.

Quality System Software – Avalign has invested in Master Control™ as our Quality system solution to ensure that we are properly and consistently managing and executing all key processes i.e., CAPA, Complaint Investigation, Change Control, etc.

Technical Competence – Avalign has made significant investment in people and tools to ensure that we have the right people and processes necessary to meet our customer requirements:

Avalign has continuously invested in "state-of-the-art" inspection equipment to ensure that critical design features are met and measured accurately and efficiently.

Quality Engineers are available at each business unit to support "design for manufacturability" activities, risk mitigation (FMEA), validation, control plans, inspection requirements, etc.

Regulatory Affairs

Avalign's regulatory affairs teams have more than 15 years experience managing a broad spectrum of regulatory submissions/approvals including clinical, design, process and sterilization validations. We have resources available at both of our US and European locations which can provide customers with regulatory assistance in both the design and development processes.